Chronic Myeloid Leukemia (CML)NCT02733445
Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib
An observational study of Chronic Myeloid Leukemia (CML), run by Bristol-Myers Squibb.
Trial summary
The purpose of this study was to determine how often and how likely patients are to develop Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy for Chronic Myelogenous Leukemia (CML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- dasatinib and nilotinib
- How many people
- 2,650 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study is based on health insurance claims data, which covers inpatient and outpatient claims from a geographically diverse area across the U.S.
Who may be able to join
- 18 years of age or older
- At least 1 prescription for nilotinib or dasatinib between 7/1/2006-12/31/2014
- Continuously enrolled in the same health plan throughout the study period
- At least 2 diagnosis codes for CML at least 30 days apart as documented in medical insurance claims
Who cannot join
- patients who had a documented diagnosis of diabetes in their medical claims or received a medication for diabetes before receiving dasatinib or nilotinib
- patients who had a documented diagnosis of high cholesterol/lipids in their medical claims or received a medication for high cholesterol/lipids before receiving dasatinib or nilotinib
About this study
Official title: Assessment of Metabolic Outcomes Among Patients With Chronic Myelogenous Leukemia (CML) Initiating Therapy With a Tyrosine Kinase Inhibitor (TKI)
The purpose of this study was to determine how often and how likely patients are to develop Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy for Chronic Myelogenous Leukemia (CML).
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- dasatinib, nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
nilotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| dasatinib cohort | Patients with CML receiving dasatinib Receives: Drug: dasatinib | |
| nilotinib cohort | Patients with CML receiving nilotinib Receives: Drug: nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
Secondary outcomes (8)
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population
Measured: approximately 101 months
risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Measured: approximately 101 months
risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Measured: approximately 101 months
risk comparison of developing Hyperlipidemia (HLD) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Measured: approximately 101 months
risk comparison of developing Hyperlipidemia (HLD) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Measured: approximately 101 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733445
- Sponsor's protocol ID
- CA180-633
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic Outcomes Among Patients With Chronic Myelogenous Leukemia (CML) Initiating Therapy With a Tyrosine Kinase Inhibitor (TKI)
- ClinicalTrials.gov ID
- NCT02733445
- Acronym / sponsor ID
- CA180-633
- Conditions
- Chronic Myeloid Leukemia (CML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,650 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine how often and how likely patients are to develop Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy for Chronic Myelogenous Leukemia (CML).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dasatinib cohort | – | Drug: dasatinibPatients with CML receiving dasatinib |
| nilotinib cohort | – | Drug: nilotinibPatients with CML receiving nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study is based on health insurance claims data, which covers inpatient and outpatient claims from a geographically diverse area across the U.S.
Key inclusion criteria (4 listed)
- 18 years of age or older
- At least 1 prescription for nilotinib or dasatinib between 7/1/2006-12/31/2014
- Continuously enrolled in the same health plan throughout the study period
- At least 2 diagnosis codes for CML at least 30 days apart as documented in medical insurance claims
Key exclusion criteria (2 listed)
- patients who had a documented diagnosis of diabetes in their medical claims or received a medication for diabetes before receiving dasatinib or nilotinib
- patients who had a documented diagnosis of high cholesterol/lipids in their medical claims or received a medication for high cholesterol/lipids before receiving dasatinib or nilotinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dasatinib | Drug | dasatinib cohort |
| nilotinib | Drug | nilotinib cohort |
Primary outcome
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
8 secondary outcomes
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population
Time frame: approximately 101 months
risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Time frame: approximately 101 months
risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Time frame: approximately 101 months
risk comparison of developing Hyperlipidemia (HLD) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Time frame: approximately 101 months
risk comparison of developing Hyperlipidemia (HLD) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy
Time frame: approximately 101 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia (CML), run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population (time frame: approximately 101 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.